Replace Select™ 37301 (UDI 07332747160819)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC NP 3.5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is placed in the jawbone to support a replacement tooth. Of its 1,114 reports, 1,096 describe injuries and 18 describe malfunctions, with no deaths. Most reports describe implants that failed to fuse with the bone, and some mention pain and infection. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,130
- Deaths reported
- 0
- Injuries reported
- 1,112
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,130 adverse event reports that list this exact device (DI 07332747160819), received between Nov 1, 2021 and Sep 30, 2026 — classified as 1,112 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (706 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate706
- Loss of Osseointegration264
- Osseointegration Problem70
- Fracture48
- Adverse Event Without Identified Device or Use Problem18
- Patient Device Interaction Problem6
- Difficult to Insert4
- Insufficient Device Problem Information4
Patient problems
- Failure of Implant852
- No Clinical Signs, Symptoms or Conditions200
- Pain128
- Unspecified Infection104
- Numbness36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available22
- Abscess12
- Implant Pain10
Recent adverse event reports
The 25 most recent of 1,130 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954303 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954297 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953309 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953308 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748519 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748517 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748516 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748514 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748483 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748482 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748427 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748426 ↗InjurySep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701233 ↗InjurySep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701232 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679062 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679061 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486963 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486962 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486905 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486900 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486724 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486722 ↗InjuryAug 8, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187839 ↗InjuryAug 8, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187837 ↗InjuryAug 4, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135576 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.